Background and objective: The prospective, randomized multicentre HOT study (Hypertension Optimal Treatment) is at present being undertaken in 26 countries. The cardinal questions to be answered were: (1) the relationship between three targeted diastolic pressures (< or = 90, < or = 85 and < or = 80 mm Hg, respectively) and cardiovascular morbidity and mortality rates among hypertensives; and (2) the effect of low dosage aspirin (75 mg daily) on morbidity and mortality rates, compared with a placebo.
Patients and methods: A total of 19,193 patients (9056 women, 10,137 men; age range 50-80 years) with a diastolic blood pressure of > or = 100 to < or = 115 mm Hg were randomized. Antihypertensive treatment was begun with the calcium-channel blocker felodipine (5 mg once daily; step 1). When the target could not be reached at this dosage, an angiotensin-converting enzyme inhibitor (ACEI) or beta-receptor blocker was added (stage two), after which felodipine, 10 mg daily, could be given, if necessary (step 3). Any necessary changes in dosage (step 4) were made according to a prescribed plan. As fifth and final step a diuretic could be additionally administered. One-year results are now available for all patients and reported here. Results of older patients (> or = 65 years, n = 6113) were compared to those of younger patients (< 65 years, n = 13,080).
Results: Average diastolic pressure in the previously < or = 90 mm Hg group had been reduced to 86 mm Hg, in the < or = 85 group to 83 mm Hg, and in the < or 80 mm Hg group to 81 mm Hg. The percentage proportion of patients in whom the targeted pressures had been reached after 12 months of treatment were: 84% for the < 90 mm Hg group, 72% in the < 85 mm Hg group and 57% in the < 80 mm Hg group. In a subgroup of elderly patients (> 65 years, n = 6113) the corresponding percentage proportions were higher: 86%, 76% and 61%. Side effects were noted only rarely, despite the intensive treatment (> 65 years and < 65 years): ankle oedema in 2.6% and 3.0%; and cough in 1.3 and 0.8%, an overall incidence of > or = 1%. The same treatment (with felodipine) was still being given after one year to 88% of all patients.
Conclusion: These results after one year indicate that most patients well tolerate consistent blood pressure reduction. This raises the hope that the primary questions of the study can be answered.